Cleared Traditional

FIRST AID KIT, EYE DRESSING (K871457) - FDA 510(k) Clearance

K871457 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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May 1987
Decision
46d
Days
-
Risk

K871457 is an FDA 510(k) clearance for the FIRST AID KIT, EYE DRESSING. Classified as First Aid Kit With Drug (product code LRR).

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fraass Survival Systems, Inc. devices

Submission Details

510(k) Number K871457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 13, 1987
Decision Date May 29, 1987
Days to Decision 46 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRR First Aid Kit With Drug
Device Class -
Definition Note: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.